Topiramate vs. Placebo in Preventing Weight Gain in Bipolar Disorder Treated With Olanzapine
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|ClinicalTrials.gov Identifier: NCT00394095|
Recruitment Status : Completed
First Posted : October 31, 2006
Results First Posted : April 4, 2013
Last Update Posted : April 4, 2013
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder Weight Gain||Drug: Topiramate Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Double-Blind, Randomized, Placebo-Controlled, Pilot Study of Topiramate vs. Placebo in Combination With Olanzapine for the Prevention of Weight Gain in Manic or Mixed Youth With Bipolar Disorder|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||September 2009|
Experimental: Topiramate Group
Patients' initial dose of topiramate 25mg bid, which was titrated over 18 days to 150 mg bid (with flexibility to titrate to 200mg bid) as tolerated.
Oral topiramate 300-400mg/day for 12 weeks
Other Name: Topamax
Placebo Comparator: Placebo Group
Matched placebo to Experimental arm
Other Name: Sugar pill
- Change in Body Mass Index (BMI) [ Time Frame: 12 weeks ]For all participants, BMI was computed using Change in BMI [kg/m2 (weight/height2)] over 12 weeks from Baseline to Week 12.
- Change in Body Weight [ Time Frame: 12 weeks ]For all participants, change in body weight in kg over 12 weeks from Baseline to Week 12.
- Tolerability of Topiramate [ Time Frame: 12 weeks ]To examine the tolerability of topiramate in combination with olanzapine for the prevention of weight gain in youth with bipolar disorder.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00394095
|United States, Ohio|
|University of Cincinnati Medical Center|
|Cincinnati, Ohio, United States, 45267-0559|
|Principal Investigator:||Melissa P DelBello, MD||University of Cincinnati|